The present invention relates to an external prosthesis and a device and method for affixing the prosthesis to the user by means of magnets compliantly housed in the prosthesis for interaction with surgical steel implants surgically inserted beneath the skin of the user. The present invention relates in particular to breast prostheses.
Various techniques are known for affixing prostheses to a user by means of magnets. For example, Stemmann (U.S. Pat. No. 5,425,763) discloses a magnet arrangement for fastening prostheses employing two or more magnets that are displaceable telescopically relative to each other to provide flexibility in the fixation of the prosthesis. One magnet is affixed to the body of the user and the other magnet is part of the prosthesis. Stemmann discloses the body-attached portion to be osseointegrated. The body-attached magnet and the prosthesis magnet are housed in titanium containers, although it is also disclosed that the containers can be of any body compatible material. Stemmann does not disclose an implant of a ferromagnetic material such as stainless steel, nor does Stemmann disclose the use of a single magnet housed within a flexible carrier.
Shiner et al. (U.S. Pat. No. 4,997,372) is typical of a number of patents disclosing magnetic fixation devices for dental prostheses. Deutsch et al. (U.S. Pat. No. 4,824,371) is also a dental fixation device employing magnets.
Freed (U.S. Pat. No. 4,004,298) discloses a connector using complementary magnetic fields to align the connector.
Sorensen et al. (U.S. Pat. No. 4,258,705) and Hennig et al. (U.S. Pat. No. 4,154,226) disclose systems employing two or more magnets to seal body openings.
Nielsen (EPO Patent Application 0392960) discloses a breast prosthesis aggregate comprising a flexible breast prosthesis and one or more fastening slabs sealable to the skin of the wearer by means of adhesive. While the primary sealing means disclosed in the application is hook and loop fastening material, it is also disclosed that the attachment slabs adhered to the skin of the wearer may be magnetic and the prosthesis may incorporate permanent magnets. Plass (UK Patent Application 2202745A) similarly discloses an adhesive attachment means employing hook and loop fastening material.
Titone et al. (U.S. Pat. No. 5,569,273) disclose a polypropylene surgical mesh.
It is desirable to provide for a prosthesis fixation method which combines the surgical implantation of a surgical stainless steel button along with a flexible carrier housing a permanent magnet with space available for a degree of freedom of movement of the magnet with respect to the flexible carrier. It is also desirable for implants to be biocompatible through the combination of layers of methymethacrylate and silastic. Furthermore, the use of a biocompatible mesh material to improve the strength of the implantation is desirable.
The limitations of the prior art are overcome by the present invention as described below.